Regulatory Recon: Express Scripts Says Prescription Spending Slowed in 2016 ACA Repeal Could Stretch to 2018 (6 February 2017)

Posted 06 February 2017 | By Michael Mezher 

Regulatory Recon: Express Scripts Says Prescription Spending Slowed in 2016 ACA Repeal Could Stretch to 2018 (6 February 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • Express Scripts says prescription drug spending slowed in 2016 (Reuters) (CNBC) (Press) (Express Scripts)
  • What if the Free Market Decided Whether or Not Drugs Work? (MIT Technology Review)
  • Trump's FDA Pick Could Undo Decades of Drug Safeguards (NYTimes)
  • Trump and Congress may make it easier to get drugs approved — even if they don't work (LA Times)
  • Editorial: Trump must follow tough talk on drug pricing with action (St. Louis Dispatch)
  • How Pharma Can Fix Its Reputation and Its Business at the Same Time (Harvard Business Review)
  • What CEOs say happened in Trump's closed-door meeting with big pharma (Washington Post)
  • Lighter regulatory touch is no reason to celebrate (Financial Times)
  • Trump says ACA repeal could stretch into 2018 (Politico) (NYTimes) (Forbes)
  • Trump Isn't Crazy (Psychology Today)
  • LabCorp explores acquisition of clinical trials firm PPD  (Reuters) (Endpoints)
  • Lilly cuts 200 R&D jobs, but insists an Alzheimer's failure is not the cause (STAT)
  • Gorsuch Looks Pretty Good On Preemption (Drug & Device Law)
  • FDA To Disclose Unredacted Advisory Committee Members' CVs (Focus)
  • Committee Recommends Adding UDIs to Insurance Claims Forms (Focus)
  • Drug company execs favor Gottlieb as Trump's pick for FDA commissioner (SNL) (Pink Sheet-$)
  • FDA Approves Infant Screen for Lysosomal Storage Disorders (Medpage) (FDA)
  • BMS, Innate checkpoint inhibitor flunks AML phase 2 (Fierce) (Pharmafile) (Endpoints)
  • FDA Issues CRL for Charleston, Daiichi Sankyo Opioid Candidate (PharmaLetter-$) (Press)
  • Sentinel Offers Drug Firms 'Unique' Venue For Post-Market Studies, Pfizer Says (Pink Sheet-$)

In Focus: International

  • Early cancer diagnosis saves lives, cuts treatment costs (WHO)
  • Spain Opens Antitrust Proceedings Against Drugmaker Aspen (Law360-$)
  • Promoting off-label use: where to draw the line? (PM Live)
  • In Brief: Brazil Adds Two More Firms to MDSAP Medical Device Quality Inspection Program (Emergo)
  • Sir Andrew Witty nears his last Glaxo goodbye (The Guardian)
  • News from Abroad -- Does an SPC for a Biological Product Cover a Biosimilar? Guidance from Norway (Patent Docs)
  • Challenges Surrounding the Development and Manufacturing of ATMPs Continue (Focus)
  • Socially vigilant: Does pharmacovigilance need secondary data & social media? (Pharmafile)
  • Slowly Does It: The EMA's Approach To Expanding Multinational Drug Assessment Concept (Pink Sheet-$)
  • Foresee Pharma advances MAA filing for cancer candidate (PharmaLetter-$)
  • Spain above the European average in clinical trials in oncology (PharmaLetter-$)
  • China issues five-year plan on HIV/AIDS prevention (PharmaLetter-$)
  • Sanofi reinforces senior staff with two new execs (Pharmafile)

US: Pharmaceuticals & Biotechnology

  • Safety and Disposal of Medications (NYTimes) (NPR)
  • FDA's 180-Day Exclusivity Q&A Guidance: Two Items of Note (FDA Law Blog)
  • Pharmacist and drug associations want better data on medicine shortages (Pharmaceutical Journal)
  • Despite years of trying, there has been little progress in Alzheimer's fight (Washington Post)
  • PhRMA's LaGanga to head state advocacy (BioCentury)
  • What is the value of a QALY? (Healthcare Economist)
  • Volunteering for clinical research: what you need to know about the informed consent process (MassDevice)
  • AZ chief: Durvalumab's ready for a 'marketing battle' against I-O heavyweights Opdivo, Keytruda (Fierce)
  • Biomedical Research Has Support, But Questions Linger About Funding (Xconomy)
  • 10 Approvals To Watch For In Early 2017 (SCRIP-$)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Priority Review for Keytruda in bladder cancer (BioCentury) (PharmaTimes)
  • Ablynx files caplacizumab for ultra rare blood disorder (PharmaTimes)
  • Taiwan's Senhwa tackles cholangiocarcinoma, gets orphan status from FDA (BioWorld)
  • Aura Biosciences Receives FDA Clearance of Investigational New Drug Application for Light-activated AU-011 for the Treatment of Ocular Melanoma (Press)
  • Intarcia's NDA filing for diabetes candidate accepted by FDA (PharmaLetter-$) (Drug Delivery) (Press)
  • Kindred Biosciences Receives Early Approval of Effectiveness Technical Section from FDA for Mirataz™ New Animal Drug Application (Press)

US: Medical Devices

  • FDA MedSun February Newsletter (FDA)
  • Edwards puts a second mitral valve trial on hold (EP Vantage)
  • Before getting a joint replacement, consider these factors (Washington Post)

US: Assorted & Government

  • Johnson & Johnson seeks new trials after $1B Pinnacle hip implant loss (MassDevice)
  • J&J breast implants "may have harmed thousands", claims fresh lawsuit (Pharmafile)    
  • Grading Obamacare: Successes, Failures and 'Incompletes' (NYTimes)
  • Affordable Care Act Sign-Ups Dip Amid Uncertainty and Trump Attacks (NYTimes) (NBC)
  • Hospitals Fear Changes to Health Law, Press GOP on Revenue Concerns (WSJ)
  • As Iraqi Immigrant, Bio CEO Sees Pros and Cons in US Travel Ban (Xconomy)
  • Waiting for the CRISPR patent decision? Here's what we know (STAT-$)
  • CVS' Shoddy Shipping Ruined Arthritis Drug, Suit Says (Law360-$)
  • AstraZeneca Prevails In Trial Over Diabetes Drug Patent (Law360-$)
  • GSK Refuses Judge's Order In Reed Smith Suicide Trial (Law360-$)
  • Judge Accepts Medicare's Plan To Remedy Misunderstanding On Therapy Coverage (KHN)

Upcoming Meetings & Events


  • Two years on, CMAL continues to prove collaboration is key to advancing our understanding of cancer and supporting research (ABPI)
  • Pyrrolizidine alkaloids in medicinal products: Risk evaluation and assays required to ensure quality and safety (SwissMedic)
  • Guideline on core SmPC and Package Leaflet for nanocolloidal technetium (99mTc) albumin (EMA)
  • Recovering the cost of NHS treatments given to overseas visitors (MHRA)


  • Japan Regulators Approve AmoyDx's Lung Cancer CDx (GenomeWeb)
  • Kyowa Hakko Kirin subsidiary set up to sell Aranesp biosimilar (BioPharmaReporter)


  • DCGI issues advisory to stakeholders on rational use of antibiotics for limiting antimicrobial resistance (PharmaBiz)


  • Mexico confirms first case of microcephaly from Zika (Reuters)
  • Antibodies from Zika patient protect mice against disease (Pharmaceutical Journal-$)

General Health & Other Interesting Articles

  • US patients have lower mortality rates with foreign-trained doctors (Reuters)
  • H. Boyd Woodruff, Microbiologist Who Paved Way for Antibiotics, Dies at 99 (NYTimes)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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